Type 2 Diabetes MellitusNCT04386200
Web-based Approach in Nutrition and Diabetes
A study testing web-based thecnologies and traditional approach in people with Type 2 Diabetes Mellitus and Overweight and Obesity, run by Università degli Studi 'G. d'Annunzio' Chieti e Pescara at 1 site in Italy.
Trial summary
The study aims to test web-based strategies, in overweight or obese participants at risk or affected by Type 2 Diabetes Mellitus , to promote adherence over time to a healthy lifestyle and nutritional medical therapy (TMN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Overweight and Obesity, Nutritional and Metabolic Diseases
- What is being tested?
- web-based thecnologies and traditional approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 13 Feb 2019to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overweight or obesity (BMI ≥25 kg/m2)
- Participants with or at risk of Type 2 Diabetes Mellitus
- Skills in the use web-based technologies and internet accessibility
Who cannot join
- Conditions that could interfere with the execution and completion of the project or failure adherence to the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Educational Approach, Clinical Nutrition and Type 2 Diabetes: Traditional Strategies and Innovative Technologies
The study aims to test web-based strategies, in overweight or obese participants at risk or affected by Type 2 Diabetes Mellitus , to promote adherence over time to a healthy lifestyle and nutritional medical therapy (TMN). The study population includes 40 subjects, randomly allocated to web group (therapeutic reinforcement through web-based strategies) or traditional group (traditional educational approach). Anthropometric and clinical parameters will be collected, as well as scores of validated questionnaires will be administered up to 12 months from the enrollment.
- Being tested
- web-based thecnologies, traditional approach
- Keywords
- Web technologies, Nutrition
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity, Nutritional and Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web-based thecnologiesOther
Integration of "traditional" face-to-face educational approach with web-based technologies.
traditional approachBehavioural
"traditional" face-to-face educational approach
| Study group | Role | What they receive |
|---|---|---|
| WEB GROUP | Experimental | Traditional approach integrated with web-based technologies. Receives: Other: web-based thecnologies |
| TRADITIONAL GROUP | Other | Traditional educational approach Receives: Behavioral: traditional approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Body Weight
Assessment of body weight (in kilograms) at baseline and after 3, 6, 9 and 12 months
Measured: Baseline, month 3, month 6, month 9 and month12
Secondary outcomes (8)
Change from baseline in BMI
Assessment of BMI (kg/m^2) at baseline and after 3, 6, 9 and 12 months
Measured: Baseline, month 3, month 6, month 9 and month12
Change from baseline in body circumferences
Assessment of body circumferences (in centimeters) at baseline and after 3, 6, 9 and 12 months
Measured: Baseline, month 3, month 6, month 9 and month12
Change from baseline in Systolic and Diastolic blood pressure
Assessment of Systolic and Diastolic blood pressure (mm hg) at baseline and after 3, 6, 9 and 12 months
Measured: Baseline, month 3, month 6, month 9 and month12
Change from baseline in fasting blood glucose
Assessment of fasting blood glucose (mg/dl) at baseline and after 3, 6, 9 and 12 months
Measured: Baseline, month 3, month 6, month 9 and month12
Change from baseline in HbA1C
Assessment of HbA1C at baseline and after 3, 6, 9 and 12 months
Measured: Baseline, month 3, month 6, month 9 and month12
Change from baseline in Dietary habits estimated by PREvencion con DIetaMEDiterranea questionnaire (PREDIMED questionnaire)
Assessment of Dietary habits at baseline and after 3, 6, 9 and 12 months. Changes in dietary habits will be estimated using a 14-item PREDIMED questionnaire which is a questionnaire to assess the adherence to the Mediterranean diet, 0 being the minimum total score and 14 the maximum total score. Higher values represent a higher adherence to the Mediterranean diet.
Measured: Baseline, month 3, month 6, month 9 and month12
Change from baseline in physical activity level estimated by the International Physical Activity Questionnaire (IPAQ) - short form
Assessment of physical activity level at baseline and after 3, 6, 9 and 12 months. Changes in the level of physical exercise will be estimated by the International Physical Activity Questionnaire (IPAQ-short form) which is a questionnaire to assess the level of physical activity. Patients are asked to measure the average amount of time spent in sedentary behaviours and different intensity levels of physical activity. The questionnaire obtains three different intensity levels of physical activity: low, moderate and high.
Measured: Baseline, month 3, month 6, month 9 and month12
Change from baseline in Quality of life by 36-item short form health survey (SF-36)
Assessment of Quality of life by SF-36 at baseline and after 3, 6, 9 and 12 months. The 36-Item Short Form Health Survey (SF-36) is a self-report generic quality of life measure. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH) with scores ranging from 0 to 100. Higher scores indicate greater self-reported quality of life.
Measured: Baseline, month 3, month 6, month 9 and month12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start13 Feb 2019
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi 'G. d'Annunzio' Chieti e Pescara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ester Vitacolonna, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386200
- Sponsor's protocol ID
- VITA02
- Status last verified
- May 2020
- First submitted
- 5 May 2020
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fraticelli F, Nicola MD, Vitacolonna E. A nutritional web-based approach in obesity and diabetes before and during the COVID-19 lockdown. J Telemed Telecare. 2023 Feb;29(2):91-102. doi: 10.1177/1357633X20966933. Epub 2020 Oct 21.
PubMed 33081596
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Approach, Clinical Nutrition and Type 2 Diabetes: Traditional Strategies and Innovative Technologies
- ClinicalTrials.gov ID
- NCT04386200
- Acronym / sponsor ID
- VITA02
- Keywords
- Web technologies, Nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Università degli Studi 'G. d'Annunzio' Chieti e PescaraUniversity, hospital or other
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to test web-based strategies, in overweight or obese participants at risk or affected by Type 2 Diabetes Mellitus , to promote adherence over time to a healthy lifestyle and nutritional medical therapy (TMN). The study population includes 40 subjects, randomly allocated to web group (therapeutic reinforcement through web-based strategies) or traditional group (traditional educational approach). Anthropometric and clinical parameters will be collected, as well as scores of validated questionnaires will be administered up to 12 months from the enrollment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WEB GROUP | Experimental | Other: web-based thecnologiesTraditional approach integrated with web-based technologies. |
| TRADITIONAL GROUP | Other | Behavioral: traditional approachTraditional educational approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Overweight or obesity (BMI ≥25 kg/m2)
- Participants with or at risk of Type 2 Diabetes Mellitus
- Skills in the use web-based technologies and internet accessibility
Key exclusion criteria (1 listed)
- Conditions that could interfere with the execution and completion of the project or failure adherence to the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| web-based thecnologiesIntegration of "traditional" face-to-face educational approach with web-based technologies. | Other | WEB GROUP |
| traditional approach"traditional" face-to-face educational approach | Behavioural | TRADITIONAL GROUP |
Primary outcome
Change from baseline in Body Weight
Time frame: Baseline, month 3, month 6, month 9 and month12
Assessment of body weight (in kilograms) at baseline and after 3, 6, 9 and 12 months
8 secondary outcomes
Change from baseline in BMI
Time frame: Baseline, month 3, month 6, month 9 and month12
Change from baseline in body circumferences
Time frame: Baseline, month 3, month 6, month 9 and month12
Change from baseline in Systolic and Diastolic blood pressure
Time frame: Baseline, month 3, month 6, month 9 and month12
Change from baseline in fasting blood glucose
Time frame: Baseline, month 3, month 6, month 9 and month12
Change from baseline in HbA1C
Time frame: Baseline, month 3, month 6, month 9 and month12
Change from baseline in Dietary habits estimated by PREvencion con DIetaMEDiterranea questionnaire (PREDIMED questionnaire)
Time frame: Baseline, month 3, month 6, month 9 and month12
Change from baseline in physical activity level estimated by the International Physical Activity Questionnaire (IPAQ) - short form
Time frame: Baseline, month 3, month 6, month 9 and month12
Change from baseline in Quality of life by 36-item short form health survey (SF-36)
Time frame: Baseline, month 3, month 6, month 9 and month12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Derived from this study: PubMed 33081596Fraticelli F, Nicola MD, Vitacolonna E. A nutritional web-based approach in obesity and diabetes before and during the COVID-19 lockdown. J Telemed Telecare. 2023 Feb;29(2):91-102. doi: 10.1177/1357633X20966933. Epub 2020 Oct 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing web-based thecnologies and traditional approach in people with Type 2 Diabetes Mellitus and Overweight and Obesity, run by Università degli Studi 'G. d'Annunzio' Chieti e Pescara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Body Weight (time frame: Baseline, month 3, month 6, month 9 and month12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04386200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.